Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
NCT ID: NCT03369132
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2017-11-06
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Angiflash
Angiflash
throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.
Placebo
Placebo
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
Interventions
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Angiflash
throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.
Placebo
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. Patients with complaint of sore throat ≤ 72h.
* 3\. Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
* 4\. Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
* 5\. Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
* 6\. Willingness to provide written informed consent prior to perform of any study related procedure.
* 7\. Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
* 8\. Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
* 9\. Subject affiliated to social security.
* 10\. Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.
Exclusion Criteria
* 2\. Active Smokers.
* 3\. Fever \> 38°C at randomization.
* 4\. Past or current throat phlegmon.
* 5\. Past or current seasonal allergy.
* 6\. Past or current asthma.
* 7\. Past or current chronic rhinosinusitis.
* 8\. Past or current chronic obstructive pulmonary disease (COPD).
* 9\. Past or current ENT (Ear, Nose and Throat) cancer.
* 10\. Acute rhinosinusitis.
* 11\. Controlled or uncontrolled diabetes.
* 12\. Gastroesophageal reflux disease (GERD).
* 13\. Known immunodeficiency.
* 14\. Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
* 15\. Any disease that may interfere with the study aim from investigator's opinion.
* 16\. Evidence of mouth breathing or severe coughing.
* 17\. Patient with severe pain intensity on 5-point descriptive pain intensity scale.
* 18\. Subjects taking:
* chronic treatment for throat or other ENT pathology,
* current antibiotherapy or stopped less than 2 weeks before inclusion,
* chronic treatment (\>3 months) with local or systemic corticotherapy, or immunotherapy,
* local or systemic antihistaminic.
* 19\. Subjects refusing to stop at entry into the study:
* throat spray, lozenge, pastille,
* local throat or systemic analgesic,
* medicated confectionary,
* nasal wash and spray,
* nasal corticosteroid or antihistaminic nasal spray,
* medication to gargle,
* honey, propolis, or any sore throat home remedies.
* 20\. Known liver disease or hypersensitivity to paracetamol.
* 21\. Pregnant, breastfeeding or seeking pregnancy women.
* 22\. Positive result from rapid strep throat test.
* 23\. Subjects already included once in this study.
* 24\. Subjects participating in another clinical trial or in the exclusion period to another study.
* 25\. Subjects having a member of his/her home who is currently participating to this study.
18 Years
ALL
No
Sponsors
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Laboratoire de la Mer
INDUSTRY
Responsible Party
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Principal Investigators
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Ivana Skardova, M.D.
Role: PRINCIPAL_INVESTIGATOR
MEDIGATE care s.r.o
Locations
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MUDr. Lenka Dybova
Brno, , Czechia
MUDr. Libor Hemzsky
Choltice, , Czechia
NEFROMED s.r.o.
Dejvice, , Czechia
MEDIGATE care s.r.o
Hradec Králové, , Czechia
MUDr. Petra Hoskova
Hradec Králové, , Czechia
MUDr. Jana Dvorakova s.r.o.
Hradec Králové, , Czechia
MUDr. Danuse Mikeschova
Karlovy Vary, , Czechia
Azita s.r.o.
Malšice, , Czechia
Fortmedica s.r.o.
Prague, , Czechia
GM ordinace s.r.o
Prague, , Czechia
MUDr Sylva Kohoutova
Prague, , Czechia
Ordinace Optima s.r.o
Prague, , Czechia
MUDr. Lenka Fejfarova
Prague, , Czechia
Saniga s.r.o.
Sokolov, , Czechia
MUDr. Jan Bartusek
Teplice, , Czechia
A-MEDICOS s.r.o.
Zlín, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Lenka Dybova, M. D.
Role: primary
Libor Hemzsky, M. D.
Role: primary
Krisitina Sadilkova, M. D.
Role: primary
Ivana Skardova, M. D.
Role: primary
Petra Hoskova, M. D.
Role: primary
Jana Dvorakova, M. D.
Role: primary
David Macharacek, M. D.
Role: primary
Azita Gebauerova, M. D.
Role: primary
Tomas Fort, M. D.
Role: primary
David Macharacek, M. D.
Role: primary
Sylva Kohoutova, M. D.
Role: primary
Radka Majerova, M. D.
Role: primary
Lenka Fejfarova, M. D.
Role: primary
Zdenek Vlasak, M. D.
Role: primary
Jan Bartusek, M. D.
Role: primary
Alena Malikova, M. D.
Role: primary
Other Identifiers
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FLASH-CZ-2017-01
Identifier Type: -
Identifier Source: org_study_id